Method and apparatus for tissue connection

ABSTRACT

A tissue connecting device is provided. The device comprise an elongate delivery device having a lumen, a proximal end, and a distal end. The distal end is configured to engage tissue and advance the device into tissue. At least one anchor deliverable through a lumen of the elongate delivery device. The distal end of the device may be designed to engage tissue upon rotation of the device about its longitudinal axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. Ser. No. 12/348,663filed Jan. 15, 2009, which is a divisional of U.S. Ser. No. 11/515,390filed Sep. 1, 2006 (U.S. Pat. No. 7,618,449), which is a continuation ofU.S. Ser. No. 10/461,861 filed Jun. 12, 2003 (U.S. Pat. No. 7,101,395),which is a continuation in part of U.S. Ser. No. 10/232,753 filed Aug.30, 2002 (U.S. Pat. No. 7,125,421), which claims the benefit of U.S.Ser. No. 60/388,250 filed Jun. 12, 2002, all of which applications arefully incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to medical devices, and their methodsof use, and more particularly to devices, and methods of use, utilizedfor the repair and reconnection of various tissues of the body. Thepresent invention may be useful in a variety of applications includingbut not limited to minimally invasive devices and methods for repair orreshaping of improperly functioning heart valves or heart tissue.

2. Description of Related Art

Bringing together tissues in closer proximity to one another is atypical means for closing wounds such as catheter puncture sites duringpercutaneous procedures (angioplasty, stenting, endograft procedures andthe like), as well as in stomach stapling for the morbidly obese,gastrostomy placement, etc. Although these procedures all may benefitfrom the inventions described herein, one particularly useful andimmediate benefit for these devices, methods and systems is in thebringing together, or coaptation, of heart valve leaflets so that theyclose properly against the relatively high pressures during thecontraction of the heart muscle so as to improve the pumping efficiencyof the heart muscle. Furthermore, the present invention additionallyprovides new and novel devices, methods and systems for the percutaneousendovascular repair of the valves of the heart and for theirmodification and subsequent improvement in cardiac valve function.

Mitral valve regurgitation is a condition in which the leaflets of theheart valve do not properly close during contraction (systole) of theheart. This permits blood to flow in a retrograde fashion from theventricle of the heart back into the atrium of the heart. The pumpingefficiency of the heart is compromised and the result, if leftunchecked, can be progressive heart failure resulting in extreme fatigueor worse and the inability of the patient to lead a normal life.

Although there are numerous reasons for damage to the valves of theheart, the typical treatment is often surgery. During surgical repair ofthe valves, the chest is usually opened, at least in part, to allowenough room for the surgeon to perform a repair or replacement of thedamaged valve. This usually requires that the patient be placed on abypass machine to pump the blood while the surgeon operates on thestopped heart muscle. For obvious reasons, this can be very traumatic onthe patient and recovery may take many months. Additionally, surgery maynot be an option for some patients due to limited possibility forrecovery, concurrent disease, or age.

For these reasons, it would be desirable to provide an alternative toopen heart surgery to modify, repair or replace a damaged heart valvewithout requiring the patient's chest to be opened and/or the patientplaced on bypass during the procedure.

SUMMARY OF THE INVENTION

The present invention provides new and novel devices, methods andsystems for the repair of the valves and for their modification andsubsequent improvement in valve function. More specifically, in someembodiments, the present invention achieves these repairs usingpercutaneous endovascular techniques that minimize trauma to the patientand provide reduced recovery time and recovery cost.

In one aspect of the present invention, a tissue connecting device isprovided. The device comprise an elongate delivery device having alumen, a proximal end, and a distal end. The distal end is configured toengage tissue and advance said device into tissue. At least one anchordeliverable through a lumen of the elongate delivery device. The distalend of the device may be designed to engage tissue upon rotation of thedevice about its longitudinal axis.

In a still further aspect of the present invention, a kit is providedfor delivering a tissue connection device to a valve having an annulusand a plurality of leaflets. The kit may include an elongate memberhaving a first substantially linear configuration when engaged with anelongate delivery device and a second substantially circularconfiguration defining a first support ring and a second support ringwhen the member disengages from the delivery device. The kit may furtherinclude instructions for use describing a method for connecting theelongate member to the valve and a package for holding the elongatemember and the instructions for use.

A further understanding of the nature and advantages of the inventionwill become apparent by reference to the remaining portions of thespecification and drawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is perspective view of an annular support device.

FIGS. 2-5 illustrate the delivery of the device of FIG. 1 to a treatmentsite.

FIG. 6 shows another embodiment of present invention for use with astraightening mandrel.

FIGS. 7A and 7B show cross-sectional views of interaction between twosupport rings to engage tissue therebetween.

FIGS. 8A and 8B are top and side views of another annular supportdevice.

FIG. 9 shows the device of FIG. 1 penetrating tissue.

FIGS. 10A-10C show the use of sutures on annular support rings inaccordance to the present invention.

FIG. 11 shows the attachment of sutures to a support ring in a linearconfiguration.

FIGS. 12-13B show various geometries of the support ring.

FIGS. 14A-14D illustrate the use of a support ring and sutures at atissue site.

FIGS. 15A-20 show embodiments of the present invention using separableclamping portions.

FIGS. 21-27D illustrate varying geometries of leaflet clamps for usewith the present invention.

FIGS. 28-30 show the delivery of an apparatus according to the presentinvention with deflectable leaflet clamps.

FIGS. 31-35 illustrate positioning of delivery devices to reach atreatment site in the heart.

FIG. 36 shows a kit containing an annular support ring and accessories.

FIG. 37 shows a suture coupled to a support member.

FIGS. 38-39 show clamps for used with shaped guide wires.

FIGS. 40-43 show delivery of anchors into tissue.

FIGS. 44-52 show additional techniques for delivering support devices totissue.

FIGS. 53-60 show various anchor embodiments according to the presentinvention.

FIGS. 61-73 show various anchor and delivery devices for use in piercingtissue.

FIGS. 74-77 show additional uses of embodiments of the presentinvention.

FIGS. 78-86 show still further embodiments of delivery devices andanchors according to the present invention.

DESCRIPTION OF THE SPECIFIC EMBODIMENTS

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed. It may be notedthat, as used in the specification and the appended claims, the singularforms “a”, “an” and “the” include plural referents unless the contextclearly dictates otherwise. Thus, for example, reference to “a material”may include mixtures of materials, reference to “a chamber” may includemultiple chambers, and the like. References. cited herein are herebyincorporated by reference in their entirety, except to the extent thatthey conflict with teachings explicitly set forth in this specification.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

“Optional” or “optionally” means that the subsequently describedcircumstance may or may not occur, so that the description includesinstances where the circumstance occurs and instances where it does not.For example, if a device optionally contains a feature for analyzing ablood sample, this means that the analysis feature may or may not bepresent, and, thus, the description includes structures wherein a devicepossesses the analysis feature and structures wherein the analysisfeature is not present.

The present invention provides new and novel devices, methods andsystems for the repair of a valve and for their modification andsubsequent improvement in valve function. More specifically, in someembodiments, the present invention achieves these repairs usingpercutaneous endovascular techniques that minimize trauma to the patientand provide reduced recovery time and cost. One particularly useful andimmediate benefit for these devices, methods and systems is in thebringing together, or coaptation, of heart valve leaflets so that theyclose properly against the relatively high pressures during thecontraction of the heart muscle so as to improve the pumping efficiencyof the heart muscle.

In the various embodiments, the devices, methods and systems of thepresent invention provide connection and/or reconnection of bodytissues, whether disconnected by trauma, surgery, disease, normalanatomy, or other means, although the devices described herein may, infact, be used during open-heart surgery or minimally invasive heartsurgery. By way of illustration, and without limitation, the devices,methods and systems are useful for the repair of the atrioventricularvalves of the heart, particularly the mitral valve. In one embodiment,it may be desirable to perform the repair endovascularly, advancing thedevices and systems through the major blood vessels leading to andexiting from the heart, and using these conduits as natural pathways forthe devices to access the valves of the heart. Although the repair ofthe mitral valve will be discussed in detail, it can be appreciated thatthe devices, methods and systems described herein can easily be adaptedto repair, connect, or bring other various body tissues into closerproximity to one another. At least some of these objectives will be metby the novel inventions, devices, methods and systems describedhereinbelow. Those skilled in the art will immediately recognize thatvarious combinations, modifications, and equivalents of the inventionsdescribed herein can be used without departing from the scope of theseinventions.

Referring now to FIG. 1, in one embodiment of the present invention, atissue connection device 10 suitable for minimally invasive deliverycomprises a first support ring or annular support ring 12 and a secondsupport ring or attached clamp 14 that secures the ring 12 to theopposite sides of the valve tissue. The first support ring 12 providessupport for the annular ring of tissue surrounding the heart valve orother target site so that proper coaptation may occur with the valveleaflets (see FIG. 5). As seen in the embodiment of FIG. 1, the firstsupport ring 12 may be substantially in a first plane while the secondsupport ring 14 may be substantially in a second plane roughly parallelto the first plane.

Referring now to FIG. 2, delivery of the device 10 may be accomplishedby straightening the first support ring 12 and second support ring orclamp 14 and inserting device 10 through an elongate delivery device 20such as, but not limited to, a guide catheter that may be used to accessthe chambers of the heart. As seen in FIG. 2, the device 10 is anelongate member that assumes a substantially linear configuration whenplaced inside an appropriately sized guide catheter. In one embodiment,the guide catheter may be sized between about 3 and 15 French (1 mm to 5mm diameter). When the device 10 is removed from the delivery device 20,the tissue connection device 10 may assume a coiled configuration asshown in FIG. 1.

Referring now to FIG. 3, the delivery device 20 such as a guide cathetermay be inserted at a location remote from the heart such as the femoralartery, brachial artery, inferior vena cava, jugular vein, etc. In thisexample, delivery device 20 is then advanced through the vessel to theheart and across the target valve. As the device 10 in a straightenedring or linear configuration is advanced out the distal end of thecatheter, the device 10 begins to regain its preformed coil or circularshape.

Referring now to FIG. 4, following deployment of the first support ring12, the delivery device 20 is pulled back to the proximal side of thevalve where the clamp portion or second support ring 14 of the device 10is deployed.

As seen in FIG. 5, the tissue connection device 10 when deployed in theheart valve captures a tissue T between the first support ring 12 andthe second support ring 14. The clamping action of device 10 reduces thedilation of the valve formed by tissue T, thus urging the leafletscloser to the center of the valve. It should be understood that, in someembodiments, configuration may be reversed where the second support ring14 is on the bottom of the valve and the first support ring 12 islocated on top. Furthermore, as seen in FIGS. 1-5, the first supportring 12 may be thicker or have a greater radial thickness than theradial thickness of the second support ring 14. The greater radialthickness may provide improved support or capture to tissue engagedbetween the rings. Additionally, the second support ring 14 having asmaller radial thickness may be more easily situated on sides of thevalve with chordae or other materials that may interfere with properdevice seating. Still further, as discussed for FIGS. 7A and 7B, thevarying thicknesses may also provide a desired reshaping of tissuecaptured between the rings 12 and 14 to reduce dilation of the valvetissue.

Referring now to FIG. 6, in another embodiment of the present invention,the device 10 may be configured for use with a straightening mandrel 30that is used as a delivery device 20 to deploy the device 10 to thetarget site. As seen in FIG. 6, the straightening mandrel 30 may passthrough a lumen 32 in the first support ring 12 and a guide loop on thesecond support ring 14. Thus in this embodiment, the tissue connectiondevice is constrained through internal straightening parts instead ofexternally constraining parts when a guide catheter is used. The device10 is loaded onto a straightening mandrel 30 or guide wire for deliveryand upon removal of the mandrel or guide wire, the annuloplasty ringand/or clamp reverts back to its pre-determined remembered shape,typically in its valve supportive configuration. The hollow device 10and its removable straightening guide wire/mandrel are also adaptablefor use with each of the other designs described within thisspecification, and is not limited to just the annuloplasty ring andclamp configurations.

Referring now to FIGS. 7A and 7B, another embodiment of the presentinvention will now be described. For ease of illustration, the rings areshown to be touching. It should be understood that tissue may be engagedbetween the rings and captured therebetween. In the embodiment of FIG.7A, the first support ring 12 has a larger circumference than the secondsupport ring 14. The ring 14 engages an inner circumferential surface 40of the first support ring 12. This provides a radially inward force asindicated by arrows 42 on an tissue captured between the rings. Theouter ring, in this case first support ring 12, may engage the tissuefirst and then the second ring 14 will engage the tissue and pull itinward. For heart valve reshaping, this will bring the valve leafletscloser to the center and reduce dilation of the valve to minimizeleakage and regurgitation.

FIG. 7B shows another embodiment where the ring 44 has substantially thesame diameter or circumference as the first support ring 12. The ring44, however, has a cross-sectional geometry wherein the ring 44 onlyengages the inner circumferential surface 40 of the first support ring12. Again, the rings will draw tissue radially inward as indicated byarrows 42.

Referring now to FIGS. 8A and 8B, the connection between the supportring 12 and the clamping ring 14 may have variations depending on thevalve anatomy, location, and disease condition. For instance in oneembodiment, it may be desired to have the connection between the twostructures in the center of the valve such that there is no interferencewith the movement of the valve leaflets (FIGS. 8A and 8B). A portion 50of the tissue connection device will be configured to extend through thecenter of the valves.

Referring now to FIG. 9, an alternative embodiment of the presentinvention has a portion 52 of the elongate member that transversesthrough the leaflet tissue towards its most outer edge where there wouldbe little or no interference with the valve leaflet. Additionally, thisposition for the connection would allow the entire device to remain outof the flow of blood through the valve opening. This would have theadvantage of no disruption of blood flow through the valve and minimizesbloodstream turbulence and the potential formation and/or dislocation ofblood clots around the device.

Referring now to FIGS. 10A through 10C, to aid in the proper seating orapposition of the valve annular support structure against the valvetissue, detachable threads or sutures may be attached at various pointsaround the device. As seen in FIG. 10A following deployment of thedistal structure, whether first support ring 12 or second support 14,the threads or sutures 60 may be pulled proximally towards the guidecatheter, thereby properly seating the structure to the underside of thevalve. At least one thread or suture 60 would aid in proper seating,preferably three, so that the orientation of the structure could beadjusted against the valve. The location of each thread or suture 60 onthe structure may be identified with unique radiopaque markers 62 tohelp in the choice of which part of the structure and whichcorresponding thread needs additional tension for optimum valve support.After positioning the device 10 but before permanent deployment, theimprovement in valve function may be assessed. Valve function may beassessed by any suitable means such as angiography, magnetic resonanceimaging, ultrasound imaging, trans-esophageal echocardiography and thelike. Following verification of improved valve function, one end of thereleasable thread could be pulled, removing the thread from itsconnection to the valve support structure. (See FIG. 37 for removal ofthread.)

Materials used in the construction of the annular support ring 12 or thesecond support ring/clamping device 14 include, but are not limited to,Nitinol, superelastic metallic alloys and plastics, PTFE, silicone,stainless steel, ceramics and/or other suitable materials orcombinations thereof. Additionally, shape-memory alloys and plastics maybe used for the support structure and/or the clamping structure in orderfor the device to be delivered in a straightened condition and, whenheated to a temperature above its transition temperature, the valvesupport structure and/or the clamping structure assume theirpredetermined geometries. In one embodiment, the temperature of the bodywould be sufficient to transform the shape of the shape-memory materialinto its ring and clamp configuration. In another embodiment, energy isapplied to the device using electrical, radio frequency, microwave,heated solutions passed through the guide catheter, or other suitableenergy source to transform the shape-memory material to its rememberedclamping and support shape. Still further, the exterior surface of thefirst support ring 12 or second support ring 14 may be conditioned toaccept penetration or engagement with a needle carrying a suture. Asseen in FIG. 10A, the surface may have a mesh or other covering 64 tofacilitate coupling with sutures 60. The mesh may be made of a varietyof materials such as Dacron® or other suitable material. For ease ofillustration, only a portion of the ring 12 is shown to be covered withmesh, though it should be understood that the entire ring may be coveredwith mesh. Other methods may also be used to facilitate such eyelets,apertures 66, anchoring locations, or connection devices on the ring 12.The ring 12 may also be made entirely of a penetrable material so thatsutures may be easily placed in the device. The ring material may alsobe made porous in order to promote endothelialization of the ring aroundthe valve. A more secure device may aid in the support the implantablering provides to the valve tissues. Suitable materials for the ringinclude Nitinol, ceramics, and plastic polymers. Additionally thematerials used may elude drugs that may assist in the promotion ofendothelialization. Alternatively, the ring may be surrounded bymaterials such as polyester that promotes tissue ingrowth andendothelialization of the device.

Referring now to FIG. 10B, in another embodiment of the device 10,sutures 60 may be secured to both the first support ring 12 and thesecond support ring 14 such that, when in its desired position, thesutures apply additional force to the rings 12 and 14 in order toincrease the clamping force between the two structures and provideadditional support to the valve's annular ring. When delivered, thefirst support ring 12 and second support ring 14 are spaced apart by adistance 70, wherein a first ring tissue engaging surface 72 isseparated from a second ring tissue engaging surface 74.

To secure the clamp section 14 and the support section 12 together, aknot and/or a clamp (or alternate securing means) for each suture 60 isadvanced from outside the body, through a guide catheter, and to thedevice using any one of several knot-tying techniques and/or toolscommonly used in vessel closure devices. Additionally, a portion of thesuture material 60 may be elastic in order to provide a constant forceto the support structure so that during the normal contractions of theheart, the device 10 is allowed limited movement relative to the valve.As seen in FIG. 10C, the device 10 when sutured together may engagetissue captured between surfaces 72 and 74 to reform the valve tissue asdesired.

Referring now to FIG. 11, the device 10 as delivered through a guidecatheter 20 with sutures attached, would look similar to the referencedillustration. Each of the pre-threaded sutures 60 attached to the ringstructure 12 line up with the corresponding points on the clamp 14 thatare located immediately adjacent to the ring attachment points when inits delivered configuration. This facilitates placement and clamping ofthe device 10.

Referring now to FIG. 12, the standard ring-shaped coil device 10described is only one configuration that may be delivered in a straightconfiguration and provide support for the valve or target tissue whendelivered to its destination. Other shapes may provide additionalsupport for one or more leaflets of the valve or may provide additionalsupport to a damaged portion of the heart valve annulus. For example inFIG. 13A, inner extensions 80 on the ring may provide a backboard forthe leaflets preventing prolapse of the valve leaflet during systole ofthe heart. In another embodiment as seen in FIG. 13B, the ring 12 may beshaped more like a bi-lobed leaf for the mitral valve, or a shamrock orcloverleaf configuration 82 for the three-leaflet tricuspid valve of theheart. The additional inner structure(s) of the cloverleaf configuration82 provides the valve leaflet with an area that it cannot physically gobeyond, ensuring proper coaptation of it and its counterpart leafletagainst its corresponding stop on the opposite side of the valve.

Referring now to FIG. 14A through 14D, a still further embodiment of thepresent invention will be described. As seen in FIG. 14A, sutures 60 maybe secured to the tissues surrounding the heart valve at anchoring sites88. The sutures may be secured in a variety of different methodsincluding but not limited to passing sutures through the heart valvematerial to be looped through or knotted off using a knot pusher. Thesutures may also be connected using anchoring devices as described incommonly assigned, copending U.S. Provisional Patent Application Ser.No. 60/388,250 filed Jun. 12, 2002.

As seen in FIG. 14B, the sutures 60 may then act as guides to advance aslideable tissue supporting member 90 over the sutures to the tissuessurrounding the heart valve. In one instance, the supporting member maybe of similar size and shape to a conventional annuloplasty ringtypically used to repair heart valves during open heart surgery. In oneembodiment, the sutures 60 may be of sufficient length to extend fromthe attachment locations in the valve tissue to outside the body toallow for attachment to device 90. The device 90 may then be slidablyadvanced over the sutures to the target tissue. This advantageouslyallows for precise anchoring of the device 90 at the target site. Asseen in FIG. 14C, the device 90 may have a single ring configurationthat may be straightened or folded (in other embodiments) to be advancedthrough a guide catheter to the target site. Alternatively, the device90 may be a continuous ring without a break, but foldable to be advancedthrough the guide catheter. As seen in FIG. 14D, a coil ringconfiguration device 92 may also be used, wherein both coils or rings ofthe device remain on the same side of the valve tissue. This may allowfor additional attachment points on the device 92 or if the coils havevarying diameters, different reshaping options based on different anglesof the sutures to provide pulling or securing forces in differentdirections.

In the invention described, the ring may be advanced over the anchoredsutures and advanced to the valve through a typical guide catheter. Insuch a manner, the entire procedure may be performed percutaneously,resulting in less trauma to the patient and providing improved valvefunction without the need for open heart surgery. After the ring is inposition on the valve tissues, each of the locations where the suturespass through the ring are fastened to the ring using the techniquespreviously described with clamps and/or knots. Alternatively, it may bepossible to secure all of the sutures with a single clamp securing eachof the sutures together, as shown in Figure, below.

Referring now to FIGS. 15A and 15B, in another embodiment of thisinvention, the device 110 consists of two separate halves or clampportions 112 and 114, each of which may provide support for the valvewhile maintaining a clamping force between them. Clamp portion 112 mayhave an annular support 113 or leaflet that supports the tissue. Clampportion 114 may similarly have an annular support 115 or leaflet thatsupports the tissue. The two clamp portions 112 and 114 are connected toeach other via a central adjustable fitting. In one embodiment, thecentral fitting consists of a barbed connector or spine 116 on onedevice part that mates to a matching insert 117 on the opposite partwith a lumen 118.

As seen in FIG. 16, the center spine 116 could be split, having a slot119, to permit the outer diameter of the spine to be adjustable,allowing the distance between the two parts to be adjusted by thephysician in-vivo, until the improved function of the heart valve hasbeen observed.

In a further preferred embodiment seen in FIG. 17, the distal end 120 ofthe center spine 116 may incorporate holes 122 on each half of thebarbs. Through the holes 122 is a releasable suture or thread 60 that,when tension is applied, compresses the two halves of the spine 116together, effectively decreasing its overall outer diameter. Thispermits the upper half of the device to be adjusted prior to release toallow for more distance between the two halves of the device and lessclamping force on the valve area. The complete assembly, including thereleasable suture, is illustrated in FIG. 18 (for illustrative purposes,the ring and clamp are shown as simple circular structures). In thismanner, the clamping force on the valve and annular support device isentirely controlled by the physician prior to its release in the heart.

In a further embodiment of the present invention as seen in FIG. 19, thedevice 110 comprises a lumen 130 through the center spine 116. The lumen130 provides a space through which a slideable and removable guide wiremay be inserted for placement of the device. A matching lumen 118 on themating half 114 of the device ensures that both pieces remain in thesame axis when being delivered. Since both parts of the connector aremaintained in axial alignment, securing the devices together isaccomplished by pushing the two devices together.

A pushing device 134 of FIG. 20, consisting of a tubular member, allowsfor tension to be placed on the releasable suture 60 without disruptingthe location of the valve support device by holding the center spine inposition while tension is applied to the suture. After the desiredimprovement in valve function has been obtained, the suture is removedby simply releasing one end of the suture and pulling on the other enduntil the entire suture has been removed from the body. Additionally,other release mechanisms include clamping jaws, screw threads, and othermechanical means, that are releasably connected to the support structurein order to maintain control over the device and to remove the structurefrom the body if improvement is not realized or for any other reason.

Again, each of the halves 112 and 114 of the device may be hollowallowing for them to be straightened over a mandrel or guide wire fordelivery into the valve area. Upon delivery to the valve are, thedevice(s) are advanced off the removable mandrel/guide wire and theyrevert back to their pre-determined shape.

In addition to the various coil type annular support rings describedabove, other types of annuloplasty device may also be used in accordanceto the present invention.

Referring now to FIGS. 21 and 22, in another embodiment of the presentinvention, a valve support structure 210 is delivered to the valve areavia a guide catheter. The device 210 comprises of a central body 212, afirst leaflet clamp 214 defining an upper compressive portion, and asecond leaflet clamp 216 defining a lower compressive portion. The clamp214 and clamp 216 may be positioned to engage the valve leaflettherebetween.

Referring now to FIG. 23, the number of leaflet clamp sets on the devicemay match the number of leaflets of the valve. For instance, the mitralvalve device of this invention may have two sets of clamps. Thetricuspid device design may, but is not required to have, three sets ofleaflet clamps 220 as seen in FIG. 23. In either instance, the clampsare connected at a central location and radiate outwards towards thevalve leaflets.

Each leaflet clamp 220 may have a different geometry, depending on thecondition of the valve. For instance, if more support is desired at theouter edge of the leaflet, the clamp could have a larger diameter inthat area. FIG. 24 shows a wire loop leaflet clamp 220 having a curvedconfiguration where the wire extends radially outward and then returnsto the central body 212. FIG. 25 shows an embodiment where the change inwidth is more pronounced as the wire loop reaches the outer radialportion of the clamp. FIG. 26 shows an embodiment having an oar orpaddle configuration. It should be understood that a variety ofdifferent geometries may be used to support the leaflet clamps.

Referring now to FIGS. 27A-27C, the cross section of the clamp 220 mayalso have various geometries. For instance, it may be desirable todistribute the clamping force over a larger area, in which case aflattened cross section would be appropriate as seen in FIG. 27B.Alternatively, rounded cross sections may be used in areas where theremay need to be increased force on the tissue surface as seen in FIG.27C.

It can be appreciated that there may be any number of configurations forthe clamps 214 and 216. For instance, if most of the support for thevalve is needed at the area of the annular ring, the clamps may notprovide any clamping force on the leaflets themselves, but would be ofsufficient overall diameter and distance away from the central hub so asto provide support in the annular area of the valve. Conversely, if apercutaneous procedure yielding similar results to the “bow-tie”procedure is desired, the clamps may be of relatively small outerdiameter. In this manner, only the leaflets would be clamped togethermore central to the device, effectively decreasing the movement of theleaflets, and providing a forced coaptation. Additionally, as seen inFIG. 27D, a combination of both annular support 222 and leafletcoaptation 224 could be achieved in the same device by providingmultiple clamps of different diameters to support both the valveleaflets and the valve's annulus.

Referring now to FIGS. 28-30, delivery of the device 210 may be achievedthrough a guide catheter 230. Each of the leaflet clamps 214 and 216 maybe made of a superelastic material such as, but not limited to, Nitinol,such that the leaflet clamps 214 and 216 can be folded up into the guidecatheter to assume a folded configuration. As seen in FIG. 28, theleaflets clamps are deflected towards a longitudinal axis 231 of thecentral body to provide a reduced diameter 232 so that the device 210will fit inside the guide catheter but still assume an expandedconfiguration with an extended diameter upon exiting the catheter.

As seen in FIGS. 29 and 30, upon release across the heart valve V, theleaflet clamps 214 and 216 return to their functioning state with theextended diameter 234. Alternatively, the device 210 may be made of anyone of a number of shape memory alloys, allowing it to be delivered in astraight configuration through the guide catheter, and re-assuming itsfunctioning form following the application of energy in the form ofelectrical, radio frequency, microwave, and such. In any case, the guidecatheter is traversed across the target valve. At the desired location,the device is pushed out the distal end of the guide catheter and uponexiting the guide catheter as seen in FIG. 29, the distal leaflet clamp214 assumes its clamping dimensions.

The guide catheter 230, still with the proximal leaflet clamps 216inside in their folded configuration, is then retracted proximallyacross the valve opening where the remainder of the device 210 isdelivered. The leaflet clamp 216 then extends to their preformedconfiguration with diameter 234, engaging or urging the valve leafletagainst the opposing clamp 214 as seen in FIG. 30.

Referring now to FIGS. 31-35, there are several ways the mitral valvecan be accessed percutaneously to deliver the devices described herein,although it should be understood that the devices may be used duringopen heart surgery as well. As seen in FIG. 31, one route utilizes thefemoral artery approach where the guide catheter 250 is threaded throughthe femoral artery in the groin and advanced retrograde against the flowof blood, over the aortic arch, through the aortic valve, into the leftventricle of the heart, and directed towards the mitral valve.

Referring now to FIG. 32, a second approach that may be used duringpercutaneous valvuloplasty procedures involves the venous approach tothe heart. The guide catheter 252 is advanced through the vena cava intothe right atrium of the heart and is directed across the atrial septumof the heart into the left atrium of the heart. This approach has beendemonstrated to be well-tolerated by the body with few adverse events.

Referring now to FIG. 33, a further method for device placement isdescribed herein that provides unique advantages for devices attemptingto modify the performance of the mitral valve percutaneously. First, atrans-septal guide catheter is advanced through the atrial septum of theheart to the superior side of the mitral valve. An extra long guide wire254, is then advanced through the guide catheter 252 and into the leftventricle. A second guide catheter 250 is advanced to the left ventricleof the heart via the arterial approach. A snare (not shown) may then beadvanced through the arterial guide catheter 250 and captures the distalend of the trans-septal guide wire 254. The snare is retracted throughthe arterial guide catheter 250 where the distal end of the guide wireis captured and secured outside the body. In effect as shown in FIG. 34,the guide wire 254 provides a passage from either or both directions,arterial or venous, to the mitral valve of the heart.

Referring now to FIG. 35, a support ring 112 when threaded over theguide wire from the arterial side need not even cross the mitral valveto provide support to the ventricular side of the valve. Similarly, asecond support ring 114 forming device 110 when combined with ring 112,intended to provide support to the atrial side of the mitral valve alsoneed not cross the valve when delivered via the trans-septal route. Inthis manner, the two halves of mitral valve device 110 can be deliveredthrough the two guide catheters and meet up at the mitral valve. Theguide wire 254 additionally ensures that the two mating parts of thedevice remain in axial alignment when assembled across the valve.

Referring now to FIG. 36, the device 10 or any of the other devices 110or 210 as described herein, may be included in a kit 300 contained in apouch or container 302. Instructions for use IFU are also contained inor attached to the container 302. The instructions provide a method forusing device 10, a method for attaching device 10 to tissue, orinstructions on how to deliver device 10 or similar device using adelivery device 20 such as a catheter or straightening mandrel that mayalso be contained in container 302. It should be understood that the kit300 may include anchors and delivery devices 500, illustrated in FIGS.78-80, in addition to or in place of devices 110 and 210.

FIG. 37 shows that sutures or threads may be removed from theangioplasty ring.

Referring now to FIGS. 38 and 39, it can be appreciated that the crosssection of the guide wire 310 may be shaped to ensure the properorientation of the two device halves. In this manner, torqueing of theguide wire 310 with the device 312 slideably attached also orients thedevice 312 loaded on the guide wire. The steerability of the guide wire310 and the valve device may help in the proper orientation of theclamps 314 of the device onto the leaflets of the valve.

Referring now to FIG. 40, additionally in a still further embodiment, anintegral bump 320 on the guide wire 322 may aid in providing additionalforce to connect the valve support device or to seat it against thetissues of the heart valve. The bump 320 on the guide wire 322 providesenough interference with the device so that as the guide wire isadvanced or retracted, it pulls the device along with it.

Referring now to FIG. 41, additional placement techniques for the deviceaccording to the present invention include using thoroscopic techniquesto place the devices. During this procedure, a small port(s) is usuallyused to access the heart tissues. The port is typically placed betweenthe ribs using laparoscopic methods. A metallic tube or guide catheteris then advanced up to the heart tissues to gain access to the majorvessels and the exterior of the heart muscle. The technique that may beparticularly useful is where the anchor is inserted through the heartmuscle at or near the level of the damaged valve.

The hypo delivery tube 330 pierces through the heart muscle into theatrium or the ventricle near the valve. The needle is then furtheradvanced across the interior of the heart to the opposite side of thevalve where it again pierces through the heart wall. The anchor 332 isthen deposited on or in the opposite side of the heart and the suture334 left behind in the path of the needle as the hypo is retracted fromthe heart muscle as seen in FIG. 42.

A clamp 336 may then be advanced down the suture to the initial side ofthe piercing. As the clamp 336 is further advanced, the sides of theheart are drawn closer to each other, assisting the valve leaflets inproper coaptation and improved function.

It should be understood that although a suture is described, a steel rodor similar support structure may be used to transverse through the heartmuscle. The main concept is that opposite sides of the valve are broughtcloser to one another by an external force on the heart muscle.Alternatively, if valvular stenosis is being treated, the valve can beforced open in a similar manner. In this manner, the spanning structureis rigid since it is under compression from the force of the heartmuscle on the spanning rod.

Yet another embodiment of the present invention comprises theventricular half of the annular support device having struts 340 insteadof a ring or clip-like structure. The struts 340 are designed toatraumatically navigate through the chordae tendonae in the ventricle ofthe heart. During advancement through the guide catheter 342, the legsare extended distally. Upon exiting from the guide catheter, the legs340 begin to spread outwards from the tip of the guide catheter towardsthe circumference of the valve. During their advancement, the legsgently push aside the chordae, if any, in their pathway.

The ends of the legs or struts 340 may be shaped in any of a number ofways to allow for either more surface area on the ventricular side ofthe valve or to advance through the chordae easier. For instance as seenin FIG. 45, small spherical bulbs 344 on the ends of the legs provide asmooth leading edge for the legs with little risk of snagging a chord asthe legs advance through the chordae. After traversing through thechordae, the landing pads on the legs secure themselves on theventricular side of the mitral valve, either at the leaflet or directlyonto the annulus of the valve. In other embodiments, the ends of struts340 may have a hockey feet 346 configuration or a zig-zag 348configuration.

Referring now to FIG. 46, another aspect of modifying the heart valvefor improved function includes devices that treat valvular stenosis.These devices provide expansive forces to the valvular annulus in orderto increase the open area of the valve through which blood flows. Onesuch device 350 utilizes an outward expansive force to apply pressure tothe annular area of the heart valve as indicated by arrows 352. The coilis delivered through a standard guide catheter and, upon exiting thedistal end of the guide catheter, the device assumes a predeterminedgenerally ring-shaped structure that presses itself against the heartwall, either immediately superior (atrial side) or inferior (ventricularside) of the valve.

Alternatively, the device may be generally cylindrical in shape, andupon exiting the guide catheter, it assumes a larger diameter thatpresses against the heart wall, either immediately superior (atrialside) or inferior (ventricular side) of the valve. Furthermore, thedevice may be hollow, allowing for it to be straightened for deliveryover a removable straightening mandrel or guide wire. Upon removal ofthe mandrel or guide wire, the ring reverts back to its larger diameterpre-determined shape and provides a force on the interior of the heartwall, thus modifying the function of the heart valve in its vicinity.

Referring now to FIG. 47, another aspect of this invention providesdevices, methods and systems for suturing and repairing tissues of thebody. Specifically, tissues can be “cinched” together, or brought intocloser proximity to one another, using the devices described herein. Inone embodiment of this invention, anchors 360 are attached to thetissues to be cinched. Attached to the anchors 360 are sutures 362. Aslideable clamp is attached to the sutures. As the clamp 364 is slidcloser to the anchor points, the tissues are brought closer together.When the desired position of the tissues has been achieved, the clamp364 is set in position and the excess suture material from each anchorpoint is severed and removed.

The anchors 360 may be of any of a number of configurations. Forinstance as seen in FIG. 48, a spear-like design would enable the anchorto penetrate tissue with the barb providing adequate resistance to thetension applied to the suture during the cinching process.

Referring now to FIG. 49, in the case of repairing a heart valve, two ormore anchor 360 may be placed in any of the tissues surrounding thevalve leaflets, including the leaflets themselves. Following the properplacement of the anchors and attached sutures 362, the slideable clamp364 is advanced over the sutures and adjusted to provide adequatetension on the anchor points on the valve to provide improved coaptationof the valve leaflets. When adequate improvement in the function of thevalve has been obtained and verified, the clamp is set in place and theexcess suture material cut and removed.

For illustrative purposes, the clamp 364 is shown as a tubular member,however, simple means of securing the tension on the sutures may beaccomplished by any one of several means. For instance as seen in FIG.50, a simple knot 366 tied in the proximal end of the sutures andadvanced towards the valve by a knot pusher, would provide adequatemeans for securing the tension in the sutures.

Referring now to FIG. 51, in another embodiment, one or more anchors 360and sutures 362 are secured to the tissues surrounding the heart valve.The sutures then act as guides to advance a slideable tissue supportingmember 370 over the sutures 362 to the tissues surrounding the heartvalve. In one instance, the supporting member 370 may be of similar sizeand shape to a conventional annuloplasty ring used to repair heartvalves during open heart surgery.

In the invention described, the support member 370 may be advanced overthe anchored sutures and advanced to the valve through a typical guidecatheter. In such a manner, the entire procedure may be performedpercutaneously, resulting in less trauma to the patient and providingimproved valve function without the need for open heart surgery. Afterthe support member 370 is in position on the valve tissues, each of thelocations where the sutures pass through the ring are fastened to thering using the techniques previously described with clamps and/or knots.Alternatively, it may be possible to secure all of the sutures with asingle clamp 372 securing each of the sutures together, as shown in FIG.52.

In one embodiment, the support member material may be made porous inorder to promote endothelialization of the member 370 around the valve.A more secure device may aid in the support the implantable ringprovides to the valve tissues. Suitable materials for the ring includenitinol, ceramics, and plastic polymers. Additionally the materials usedmay elude drugs that may assist in the promotion of endothelialization.Alternatively, the support member 370 may be surrounded by materialssuch as polyester that promotes tissue ingrowth and endothelializationof the device.

Referring now to FIG. 53, in another aspect of this invention, theanchors 360 incorporate a loop 376 of material or a lumen through whicha suture may slide 380. The first anchor 360 placed typically has anon-slideable suture attached. Once the first anchor point has beensecured in the desired location, subsequent anchors 378 are slid overthe primary suture and secured to the tissues of the valve.

As tension is applied to the primary suture 380, each of the anchorpoints are brought into closer proximity to one another (see FIG. 57),resulting in improved coaptation of the valve leaflets and improvementin the function of the heart valve. Following the final anchorattachment to the tissues, a single clamp 372 or knot is advanced to thelocation of the final anchor and secured in place following verificationof improved function. Valve function may be verified by any one of manysuitable means including, but not limited to, echocardiography,angiography, magnetic resonance imaging, etc.

Referring now to FIG. 54, the anchors may be of any suitable design toprovide adequate prevention of dislodgement when the primary suture isplace in tension. An alternative embodiment to the barbed spear is a “T”bar design anchor 382 is used in various alternative procedures such asin gastrostomy placement.

Referring now to FIG. 55, in one embodiment, the “T” bar 382 is placedvia a hypodermic needle or tube 384. The needle 384 punctures throughthe tissues to be cinched and then the “T” bar 382 is deposited on theopposite side by a simple mandrel or “T” bar pusher. The needle is thenretracted leaving the “T” bar anchor securely fastened to the oppositeside of the tissue as seen in FIG. 56.

Subsequent anchors are added by removing the “T” bar pusher from thecatheter, loading a slideable anchor over the primary suture, andadvancing the anchor through the hypo tube to the next desired position.The target tissue is then pierced by the “T” bar delivery hypo tube, the“T” bar anchor pushed out the end of the hypo, and the hypo retracted,leaving the “T” and primary suture attached to the anchor point.Additional anchors may be placed in a similar fashion as seen in FIG.57.

Referring now to FIG. 58, in this manner, multiple anchor points 388 maybe placed around a heart valve or other tissue that is in need ofsupport. As tension is applied to the primary suture, the anchorsprovide the points at which constriction occurs and the overall diameterof the valve annulus is reduced much like the use of a belt through thebelt loops on a typical pair of trousers. By this method, several seriesof anchors and sutures may be placed that specifically providesconstriction on only those areas of the valve that may be in need ofcinching.

It is important to note that although the repair of the heart valve isdescribed, this device and technique may also be very useful in thenon-surgical repair of other tissues within the body. For instance,Gastrointestinal Reflux Disease may be treated by using these techniqueson the sphincter between the esophagus and the stomach. By effectivelydecreasing the overall diameter of the excess opening typical of thisdisease, normal function may be restored. Additionally, urinaryincontinence may be treated using similar techniques and devices on thesphincter between the bladder and the urethra. In these instances andothers, surgery may be significantly reduced or eliminated, thus sparingthe patient from the risks of surgery and the necessary recovery fromsuch trauma.

Referring now to FIG. 59, another technique that can be used is whereeach of the anchors 390 are slidable with no primary anchor. Instead ofthe initial anchor having a permanent suture attached, a single (ormultiple strands) suture 392 is threaded through a hoop on each of theanchors 390 with both ends of the suture exiting through the deliveryguide catheter. The tissue is then cinched together by advancing a knotor clamping device 364 using the two ends of the suture as the pointwhere the tension is applied.

Referring now to FIG. 60, if a clamp 364 is advanced towards theanchors, the clamp itself may have a means to both clamp the ends of thesuture together and simultaneously cut the excess suture material fromthe site. FIG. 60 shows a clamp 400 with a crimping area 402 and acutting area 404.

Another method is where each of the anchors has non-slidable suturespermanently attached. In this instance, all of the ends of the suturescan be pulled together, and tied or clamped with a single knot orclamping device.

Referring now to FIG. 61, the hypodermic delivery tubing 410 for the “T”bar anchors or similar anchors may be of any number of suitableconfigurations to deliver the anchors. In one embodiment, the tubing 410employs a simple sharpened needle tip 412 to puncture through the valve,leaflets, and/or the heart tissues surrounding the valve. Theapplication of forward pressure on the tubing provides sufficient forcefor the tubing 410 to pierce the tissues and deliver the anchor to theopposite side of the heart structure.

Referring now to FIG. 62, in another embodiment, the tubing 414 has asharpened inner removable piercing obturator 416 that punctures throughthe heart tissues. After the tubing is through the tissues, theobturator is removed, allowing the anchor to be passed through the hypotubing to the heart tissues.

Referring now to FIG. 63, in another embodiment, the obturator tip 418has self-tapping threads 420 on its distal end. Torqueing of theobturator screws the delivery hypo into the heart tissues. After thehypo 414 has been delivered to the desired location, the obturator isremoved, allowing the anchor to be passed through the hypo tubing.

Referring now to FIG. 64, in another embodiment, the hypo tube 422 hasthreads 424 on its surface to permit the engagement of the hypo tube 422with very little force. Torqueing of the hypo tube 422 screws the tubinginto the heart tissues without requiring additional forward force on thetubing. In some cases, it does not require forward force greater thanthat used with a sharpened hypo tube. Once through the tissue, anchorsmay be advanced through the hypo 422 to their desired position.

Referring now to FIG. 65, another embodiment utilizes self-tappingthreads 420 on both the inner cannula 426 and the outer delivery hypotube 428, preventing the possibility for coring of the tissue with thehypo tubing alone.

Referring now to FIG. 66, in yet another embodiment, the anchor 430itself employs self-tapping threads 420 to engage the tissue and advanceitself to the opposite side of the targeted tissue.

Referring now to FIG. 67, alternatively, the anchor 432 may be a simpleself-tapping thread or a helix of sharpened wire similar to the distaltip on an active-fixation pacemaker lead that is secured to the hearttissue by torqueing through the tissue.

Referring now to FIG. 68, one possible improvement on the helical anchor434 is that the helix may be of variable radii. For instance, theinitial distal engaging winds of the helix may be of relatively smalldiameter, increasing in diameter proximally.

Referring now to FIG. 69, in this instance, additional anchoring forceis provided, allowing for a more secure attachment. Additionally, thesuture material 440 may be attached to the distal end 442 of the helixsuch that as more force is applied to the anchor by the suture, theanchor 444 tends to collapse upon itself, further providing additionalsupport to the tissues in which it is attached.

Referring now to FIG. 70, delivery of the anchor 432 is accomplished bysecuring the anchor 432 to a releasable delivery shaft 446. In onemethod of delivery, the anchor 432 is secured to the heart tissue byclockwise motion. Engaging threads 448 on the delivery shaft 446 allowsclockwise rotation of the anchor for securement. Counterclockwiserotation of the delivery shaft 446 disengages the anchor 432 from thethreads 448 on the delivery shaft. The delivery shaft is then removedfrom the guide catheter, leaving the anchor firmly secured within theheart tissue.

Referring now to FIG. 71 in another embodiment, the distal end of theguide catheter 450 releasably locks or engages at least a portion of theanchor 432. The anchor 432 is delivered with the engaging portion of theguide catheter retracted, and following delivery of the anchor, theguide is then advanced up to the anchor point to engage a portion of theanchor. By rotating the delivery shaft 450, the anchor is held in place,while the delivery shaft disengages. The guide catheter is thenretracted from the anchor, leaving the anchor secured to the tissue.

Referring now to FIG. 72, another method of delivery for the anchors isthe simultaneous deployment of multiple anchors 460 at a time. In thismanner, the delivery shafts 462 for two or more anchors are deployed ata variable distance apart. For instance, the ends of the delivery shafts462 may be pre-shaped into a curved geometry such that as they exit theguide catheter, they progressively move further apart from each other.

Referring now to FIG. 73, the more the delivery shafts 462 are advancedout the guide catheter, the greater the distance between the anchors460. In this manner, several anchors 460 can be delivered in apre-determined configuration at a pre-determined diameter away from theguide catheter. This eliminates the need to individually place eachanchor at a desired location. Each projection outward from the guidecatheter tip need not contain an anchor. In other words, one or moreadditional projections 464 may be used to center the device within thelumen of an artery or within the valvular tissue such that the anchorsbeing delivered are oriented in the desired directions.

The anchor(s) may be porous in order to promote the endothelializationor encapsulation of the anchor in the tissue to obtain a more secure,long-term hold in the valve tissue. Suitable materials include ceramics,nitinol, elgiloy, stainless steel and the like. Alternatively, variouspolymers may be used that may or may not elude drugs to further promoteendothelialization of the heart tissues into and around the anchorsand/or the various other devices and inventions described herein.Additionally, the device may be used to close tubular organs, puncturesor vessels from inside the tissues. In one instance, the fallopian tubesof a woman may be closed for permanent birth control. The device isthreaded through a fallopian tube access catheter trans-cervically tothe interior of the fallopian tube. One or more anchors may be deliveredthrough the wall of the fallopian tube from the inside. The anchors arethen secured to the exterior of the tubal wall and cinched together toclose the tube. A clamp or knot that provides closure force is advancedto the site and secures the individual suture leads together. Again, thesutures may be fibered, stranded or bundled in order to facilitatetissue ingrowth and a more permanent occlusion of the fallopian tube. Inthis same fashion other organs, tissues and body passageways may beclosed from the inside in order to effect the desired therapy ortreatment.

Referring now to FIG. 74, another aspect to the delivery of the anchorsis in providing a means for the guide catheter to grip or hold thetissues in close proximity to the distal end of the guide catheter. Onesuch means is the provision for a simple vacuum to be placed on theproximal end of the lumen of the guide catheter 470. As the tip of theguide comes close to a soft tissue, the tissues are sucked closer to theguide catheter tip and held in place by the suction.

This vacuum device, the guide catheter 470 with an attached ordetachable vacuum source, may also be particularly useful in thefixation of the stomach wall prior to percutaneous gastrostomyplacement.

Referring now to FIG. 75, it is important to note that the anchors 460may provide a means to improve the function of the heart valve alone,they may also be used to provide an anchoring means for various otherdevices used in the interventional treatment of cardiovascular diseases.For instance, although providing a means to secure the percutaneousannuloplasty rings described earlier, they may also be used to secure oraffix a stent 480, or stent-graft to a vessel wall. In this application,first the anchors are delivered and secured to the desired tissue, suchas the abdominal aortic vessel wall. The sutures on the anchors arethreaded through loops such that the stent device can slide over thesutures. The stent is then advanced to the anchoring site. Knots orclamps are then advanced up to the stent so that the stent is thensecured to the vessel wall at each of the anchor points.

Alternatively, the anchors may be added after the stent has beendelivered. The stent has specific points of attachment through which theanchors are delivered into the vessel wall. In this manner, the need forany suture material is completely avoided as seen in FIG. 76.

Referring now to FIG. 77, another aspect of this invention is anartificial valve 490 to replace a destroyed natural valve within thebody. The natural valve may be one of the heart such as the mitral oraortic valves. Alternatively, the valve may be used in the legs of apatient with venous insufficiency. By providing improved fluid dynamicsover the patient's natural valve(s), pooling of blood in the legs,typical in this disease, is minimized. The valve device 490 includes thevalve itself, as well as an outer expandable support structure thatsecures the valve within a desired segment of blood vessel. The valve490 may be made from materials typical of cardiac valves, such ascarbon, silicone, nitinol and the like. Alternatively, the valve of thisinvention may be a tissue valve from a donor host, similar to porcine orbovine valves used for cardiac valve replacement. The valve may beprocessed venous valves from these animals, or they may be made from avalve structure that is temporarily grown within the living tissues of ahost animal.

Yet another aspect of this invention provides a means for repairing thechordae tendonae that connect the leaflets of the mitral valve to theventricular wall. In this device, the anchor is directed through theleaflet of the valve from the atrial side of the heart and placed withinthe ventricular wall. The leaflet is held in place by a knot or a clampsecured to the atrial side of the leaflet onto the suture attached tothe anchor. Several sutures may be place in each of the leaflets inorder to prevent prolapse during systole of the heart.

Referring now to FIG. 78, a still further embodiment of a tube 500 forengagement of the tube 500 into tissue with reduced forward force.Torqueing of the tube 500 screws the tubing into the tissues through thecutting action of the helically cut distal portion 502 of the tube 500.Although not limited to the following, the cutting distal portion 502may be formed by laser cutting or otherwise cutting a tube to removematerial and form the structure shown. Other patterns may also be cut inthe tube so long as they permit the tube to be advanced into tissue viatorquing of the tube 500. Once through the tissue, anchors 504 may beadvanced through the tube 500 to their desired position. In someembodiments, a pusher 506 may be used. In some embodiments, the anchor504 may have a diameter substantially similar to that of the innerdiameter of the tube 500 but allowing for unimpeded delivery of theanchor through the tube. A suture 506 may be coupled to the anchor 504.

Referring now to FIG. 79, one embodiment of the tube 500 or elongatedelivery device is shown penetrating through tissue T and delivering theanchor 504. Arrow 510 indicates that rotation of the delivery device 500will cause the distal end 502 of the device 500 to engage tissue anddraw the entire device 500 into and through the tissue. In someembodiments, anchor 504 may have a sharpened tip as indicated by dottedline 512 to allow the anchor 504 to be driven through the tissue.

Referring now to FIG. 80, in this embodiment, a guide catheter 520 maybe used to guide the elongate delivery device 500 into the correctlocation for penetration into tissue T. It should be understood that thetube or device 500 may have any of the distal tips disclosed herein andmay be used with any combination of anchors disclosed herein. The tube500 may be rotated within the guide catheter 520 to enable the front endof the tube 500 to engage tissue. In other embodiments, the tube 500 issimply pushed forward to pierce the tissue T.

Referring now to FIGS. 81 and 82, the support member 530 after beingdelivered to a target site, may use a suture 532 to tighten the tissuecoupled to the support member 530. The member 530 may be secured byanchors or sutures as described in regards to FIGS. 14A-14C and FIG. 51.

Referring now to FIGS. 83 and 84, the anchors 504 may be deliveredthrough tissue using a delivery device 500 or the like to send an anchor504 through tissue T. This technique may be useful in patent foramenovale (PFO) closure in heart tissue. As seen, a suture 540 with anchors504 may be used for tissue connection.

Referring now to FIGS. 85 and 86, a still further embodiment of ananchor 550 is shown. The anchor 550 has outward extending member 552 orbarbs which will secure the anchor in tissue after delivery from thecatheter 500. This may be useful in situations where the anchor 550 doesnot fully penetrate through tissue and may rely on the barbs foranchoring force.

While the invention has been described and illustrated with reference tocertain particular embodiments thereof, those skilled in the art willappreciate that various adaptations, changes, modifications,substitutions, deletions, or additions of procedures and protocols maybe made without departing from the spirit and scope of the invention.For example, the geometric configuration of the loops of device 10 or210 may be varied as desired to provide leaflet support, includingshapes such as square, triangular, bowed, rounded, or otherconfiguration. The wire loop elements may also be replaced by solidelements, such as a solid, oar shaped clamp instead of a wire loop.Although device 10 is generally shown to have a circular relaxedconfiguration, it should also be understood that, in all embodiments,the device may have a square, rectangular, triangular, polygonal, orother shape that will provide suitable reduction of valve regurgitation.Additionally, bringing together tissues in closer proximity to oneanother is one method for closing wounds such as catheter puncture sitesduring percutaneous procedures (angioplasty, stenting, endograftprocedures and the like), as well as in stomach stapling for themorbidly obese, gastrostomy placement, etc. These procedures all maybenefit from the inventions described herein. Additionally, any of theinventions and devices described in this application may bemanufactured, at least in part, using animal, human or cultured cellsand tissues incorporated in whole or in part. These tissues may beharvested or cultured though tissue engineering or altered by themanipulation of their genetic content. In such a manner, these devicesmay be incorporated into the target location easier, may be less proneto rejection by the body, or may elude certain chemicals and/or enzymesthat may be beneficial to the targeted tissues or the body as a whole.

Expected variations or differences in the results are contemplated inaccordance with the objects and practices of the present invention. Itis intended, therefore, that the invention be defined by the scope ofthe claims which follow and that such claims be interpreted as broadlyas is reasonable.

The invention claimed is:
 1. A tissue anchor assembly, comprising; ahelical tissue anchor capable of piercing tissue through rotation, asuture coupled to a distal end of the helical tissue anchor andconfigured to provide that as more force is applied to the helicaltissue anchor by the suture, the helical tissue anchor collapses uponitself and provides additional support to tissues in which it isattached; a tissue support member; a clamp coupled to the suture toprovide tension between the tissue support member and the anchor, and areleasable elongated delivery device with a distal end configured toreleasably engage the anchor, the elongated delivery device includingengagement threads that allow rotation of the helical tissue anchor forsecurement.
 2. The assembly of claim 1, wherein at least a portion ofthe tissue support member is a mesh slideably coupled to the suture. 3.The assembly of claim 1, wherein the anchor has a helix geometricconfiguration.
 4. The assembly of claim 1, wherein the anchor is made ofat least one of metal or a polymer.
 5. The assembly of claim 1, whereinat least a portion of the anchor is sufficiently porous to provide fortissue in-growth.
 6. The assembly of claim 1, wherein the anchorincludes medicamant delivery to tissue.
 7. The assembly of claim 1,wherein the anchor incorporates at least one of, a healing hormone or acomposition that provides a therapeutic response to tissue.
 8. Theassembly of claim 1, wherein the suture is at least one of, amonofilament and a braided multifilament.
 9. The assembly of claim 1,wherein the suture is made of a material that is absorbable.
 10. Theassembly of claim 1, wherein the suture is configured to deliver amedicament to tissue.
 11. The assembly of claim 1, wherein the suture isporous to promote tissue in-growth.
 12. The assembly of claim 1, whereinat least a portion of the tissue support member is made of mesh.
 13. Theassembly of claim 12, wherein the mesh is configured to provide supportto at least one of a urethra and bladder.
 14. The assembly of claim 12,wherein the mesh is configured to provide support to a vagina.
 15. Theassembly of claim 12, wherein the mesh is woven of a monofilament. 16.The assembly of claim 12, wherein the mesh is made of a polymer.
 17. Theassembly of claim 12, wherein the mesh is configured to deliver amedicament to tissue.
 18. The assembly of claim 12, wherein themedicament is selected from at least one of, estrogen, estrodiol, asubstance that promotes tissue in-growth and a substance that provides atherapeutic response to tissue.